Grass Pollen Allergy, Rhinoconjunctivitis
Conditions
Keywords
Retention, Motivation, Self-Determination Theory, Grass Pollen Allergic Rhinoconjunctivitis, Intralymphatic Immunotherapy, Patient and Public Involvement
Brief summary
The motivation-enhancing intervention is designed for participants in the ILIT.NU trial. The participants are patients with hay fever who are treated with a vaccination in an inguinal lymph node. The motivation-enhancing intervention is a web-based app developed in collaboration with patient partners and is intended to increase retention and reporting in the ILIT.NU trial.
Detailed description
The ILIT.NU trial (EudraCT 2020-001060-28) investigates whether patient reported outcome measures compound symptom-medication score (cSMS) are relieved by intralymphatic immunotherapy (ILIT). The participants are asked for a three-year period to attend annual consultations and to daily fill in an online questionnaire about their allergy symptoms and medication use during the grass pollen season (100 days). High attrition rates have been a problem in previous ILIT trials. High attrition affects generalizability, validity and reliability of a trial. To increase retention and reporting in the ILIT.NU trial, a motivation-enhancing web-based app has been developed. The web app is based on the Self-Determination Theory and is developed in collaboration with patient partners and clinicians. Participants are randomized across treatment group to either the motivation-enhancing web app or the standard reporting method. The project is conducted as a Study Within a Trial (SWAT).
Interventions
OTHERMotivation-enhancing intervention
The web app is designed as an efficient and easy-to-use app configurable to personal preferences. Each day participants receive a text message on their smartphone with a link for the daily cSMS questionnaire. The questionnaire addresses the same questions as the questionnaire in the standard intervention, but the format is different, and some shortcuts makes it easier to answer. When the questionnaire is answered, the web app gives access to different features. The following features distinct the motivation-enhancing intervention from the standard intervention (1) only complete the entire questionnaire on days with symptoms, (2) integration of grass pollen counts and forecasts, (3) showing personal response rate, (4) access to own data via a graph, (5) advice against grass pollen allergy, (6) status of the study, (7) individually choosing the time of response, (8) option to download an icon for the home screen and (9) contact information. The development is an ongoing iterative process
Each day participants receive a text message on their smartphone with a link for the daily cSMS questionnaire. When the questionnaire is answered, the tab needs to be closed.
Sponsors
Aarhus University Hospital
Innovation Fund Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Participants are randomized 1:1 across treatment group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants enrolled in the ILIT.NU trial
Exclusion criteria
* Participants not enrolled in the ILIT.NU trial, Denmark
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of reporting daily cSMS data | 16 weeks | Increased reporting will be compared within and between the intervention group and the control group, to evaluate the effectiveness of the motivation-enhancing intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 16 weeks | Increased retention measured as loss to follow up, where drop outs from the ILIT.NU trial will be compared within and between the intervention group and the control group, to evaluate the effectiveness of the motivation-enhancing intervention |
| Motivation | 14 days | Increased motivation measured by the Intrinsic Motivation Inventory Questionnaire, to evaluate the effectiveness of the motivation-enhancing intervention |
| Participant experience with the web-based app | 12 weeks | 10 participants are invited to a focus group interview to discuss their experiences with the web-based app |
Countries
Denmark
Outcome results
None listed